NCT01199497撤回3 期
Multicenter Clinical Trial Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Diphenhydramine + Pseudoephedrine + Dropropizine in the Control of Cough and the Relief of Nasal Symptoms in Subjects Above 12 Years of Age, Suffering From Non-productive Cough and Acute Rhinitis.
Ache Laboratorios Farmaceuticos S.A.0 个研究点开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Primary efficacy criteria
研究概览
简要总结
Multicenter clinical trial, phase III, controlled by active medicine, double-blind, randomized, enroll 208 subjects, above 12 years old, that suffer acute inflammation upper airway characterized by non-productive cough, daytime/nighttime, with duration for at least 3 and no more than 5 consecutive days (without systemic/topic use of medication during this period) followed by nasal congestion, with or without associate other nasal symptoms (sneezing, runny nose, nasal itching and/or mouth breathing). The subjects will be allocated in 2 parallel groups, and will receive the medicines of study, according of the randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 12 years old, of both sexes;
- •Clinical condition compatible with acute rhinitis accompanied by nasal congestion;
- •Non-productive cough, daytime and/or nighttime with at least 3 and up 5 consecutive days in duration;
- •Score greater than or equal to 3 points on the cough severity score (As per item 4.1.2);
- •Score greater than or equal to 2 points on the nasal congestion severity score (As per item 4.1.3);
- •If necessary, ICF signed by a parent/representant, or in case the patient over 18 years old, his own signature;
- •Patient and/or representant capacity, according to investigator evaluation, for compliance at the treatment and protocol requirements, fulfilling the regular visits;
排除标准
- •Non-productive cough with purulent smear, fever (axilar temperature superior than 37,8°C/100°F), purulent runny nose and other signs and symptoms of bacteria infection of upper and lower airways at 7 days before the screening/randomization visit;
- •Septal deviation level III (in any region and any nasal cavity) and/or nasal polyps or other determinants conditions of nasal congestion;
- •Previous diagnosis of asthma;
- •Female patients with positive b-HCG;
- •Patients under treatment for chronic allergy;
- •Presence of purulent or mucupurulent secretion, nasal vault or mal formations (cleft lip or cleft nasolabial corrected or not) in nasal vestibule;
- •Current use of systemic antibiotics for any reason;
- •Use of prohibited medicine within the prescribed period before V0 as shown in item 9.3 of this protocol;
- •Participation in last one year of clinical protocols;
- •Any psychiatric diseases, including major depression;
- •Presence of mental retardation from any cause;
- •Diagnosis of renal or hepatic failure;
- •History of hypersensitivity to any component of the study drugs;
- •Relatives of sponsor´s or study site´s employee;
- •Current evidence of clinically significant diseases: hematopoietic, gastrointestinal, cardiovascular, hepatic, renal, neurological, endocrine, psychiatric, autoimmune, pulmonary, or another disease that block the patient participation;
- •Patient or parent/representant with a history of lack of compliance to treatment or previous treatment protocols;
- •Any finding of clinical observation (anamnesis and physical exam) laboratory abnormality (eg, blood glucose, blood count), disease (for example, liver, cardiovascular system, lung) or therapy that, in opinion of the investigator, may endanger the patient or interfere with the endpoints of study.
研究组 & 干预措施
Group 1
Experimental
Fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).
干预措施: Group 1 (Drug)
Group 2
Placebo Comparator
Placebo
干预措施: Group 2 (Drug)
结局指标
主要结局
Primary efficacy criteria
时间窗: baseline and week 24
The changes of lung function parameter: pre-bronchodilator forced expiratory volume in first second (FEV1) including baseline and 24th week.
次要结局
- Secondary efficacy criteria(baseline, week 8, 16 and 24)
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